Kornimate/medical-research-clean huggingface dataset:
the effects of sedentarism on vascular function, inflammation, and insulin resistance

Conditions: Endothelial Dysfunction; Insulin Resistance; Metabolic Syndrome; Peripheral Arterial Disease

Summary: the purpose of this study are twofold: 1. to understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation; 2. to assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.


Eligibility criteria:
inclusion criteria: * healthy subjects: subjects must be free from any acute, chronic or debilitating medical conditions. healthy status will be established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, a physical examination, and where necessary a chest radiograph. exclusion criteria: * any active acute or chronic medical problem: any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) will be excluded from study. the exclusion criteria will also include history or evidence for psychiatric disorders, hypertension, diabetes, coronary artery disease (cad), renal insufficiency, thyroid disease, alcohol or drug abuse, viral hepatitis, deep venous thrombosis or anemia. individuals with a history of psychiatric illnesses or psychiatric disorders will also be excluded, such as alcoholism, drug dependency including dependency on tobacco, major mood disorders such as major depression and manic depressive illness, schizophrenic disorders, anxiety disorders including panic disorder, generalized anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder. in addition, potential subjects with a first order relative with a history of major depressive illness, manic depressive illness, schizophrenia, agoraphobia or panic disorder will also be excluded from entry to this study. finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers will be excluded from study. however, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not necessarily be exclusionary.

Keywords: sedentarism physical inactivity fish oil omega-3 fatty acids endothelial dysfunction insulin resistance metabolic syndrome peripheral arterial disease
efficacy and safety of danggui-sayuk-ga-osuyu-saenggang-tang on korean patients with cold hypersensitivity in the hands

Conditions: Cold Hypersensitivity

Summary: the purpose of this trial is to investigate the efficacy and safety of danggui-sayuk-ga-osuyu-saenggang-tang(dsgost) on korean patients with cold hypersensitivity in the hands


Eligibility criteria:
inclusion criteria: 1. female subjects aged 19 to 59 years have a complaint of chh. 2. patients must include at least one or more of the following symptoms: * those who have the symptoms of chh in normal temperature which most individuals feel no cold; * those who have the symptoms of extremely cold hands in cold temperature exposure; * those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed; 3. those who have 4 cm or greater of vas chh score; 4. a thermal differences between the palm (pc8) and the upper arm (lu4) may be higher than 0.3℃; 5. those who can comply with all study-related procedures, medications, and evaluations; 6. given a written informed consent form. exclusion criteria: we will exclude patients who have taken 1. patients with calcium antagonists or beta-blockers with the purpose of treating chh; 2. those who have one or more finger gangrene or ulceration; 3. those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs; 4. those who are diagnosed by autoimmune disease or have a positive ana test result; 5. those who are diagnosed by carpal tunnel syndrome or have a positive tinel and phalen's tests; 6. those who are diagnosed with cervical disc herniation or (malignant) tumor disease; 7. those who are diagnosed with diabetes; 8. those who are currently medicated to drugs that may affect to chh symptoms, such as anticoagulants etc; 9. those who have moderate level of liver dysfunction (each of ast, alt greater than 100 iu/l) or kidney dysfunction (cr 2.0mg/dl); 10. those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness; 11. those who are diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (hgb) level less than 7g/dl, hematocrit (hct) level less than 26%, white blood cell (wbc) level greater than 11,000/mm3); 12. those whose systolic blood pressure (sbp) 180mmhg or diastolic blood pressure (dbp) is greater than 100 mmhg based on average value of at least 2 measurements; 13. those who are suspected arrhythmia that showing up on ecg, or diagnosed by heart diseases, such as, ischemic heart disease and so on; 14. those who are addicted to alcohol or drugs; 15. those who are pregnant (positive urine-hcg) or lactating or have the chances of pregnancy; 16. those who are currently participated in other clinical trials; 17. those who are able to understand and speak korean; 18. those who are judged to be inappropriate for the clinical study by the researchers.

Keywords: cold hypersensitivity in the hands korean medicine dsgost
a study to evaluate the efficacy and safety of glecaprevir (gle)/pibrentasvir (pib) in treatment-naive adults in brazil with chronic hepatitis c virus (hcv) genotype 1 - 6 infection

Conditions: Hepatitis C Virus (HCV)

Summary: this was a phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (gle)/pibrentasvir (pib) for an 8 or 12-week treatment duration in adults in brazil with chronic hepatitis c virus (hcv) genotype (gt) 1 to gt6 infection, without cirrhosis or with compensated cirrhosis, who were hcv treatment-naïve.

this was a phase 3, open-label, multicenter study to evaluate the efficacy and safety of gle/pib for an 8- or 12-week treatment duration in adults in brazil with chronic hcv gt1 to gt6 infection, without cirrhosis or with compensated cirrhosis with a metavir system fibrosis score of f2 to f3 (without cirrhosis) or f4 (with compensated cirrhosis) or equivalent, who were hcv treatment-naïve.

Eligibility criteria:
inclusion criteria: * participant had positive plasma hepatitis c virus (hcv) antibody and hcv ribonucleic acid (rna) viral load greater than or equal to 1000 iu/ml at screening visit. * participant must have been documented as without cirrhosis with metavir equivalent fibrosis stage of f2 to f3 or with compensated cirrhosis (f4) based on results of a liver biopsy, or fibroscan, or fibrotest score. * participants who were known to be hcv/human immunodeficiency virus (hiv) co-infected may have been enrolled if they had a positive test result for anti-hiv antibody at screening and were: naïve to treatment with any antiretroviral therapy (art), or on a stable, qualifying hiv art regimen for at least 8 weeks prior to baseline. * participants with compensated cirrhosis only: absence of hepatocellular carcinoma (hcc) within 3 months prior to screening or a negative ultrasound at screening. exclusion criteria: * current hepatitis b virus (hbv) infection on screening tests. * any current or past clinical evidence of child-pugh b or c classification (score of \> 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding. * receipt of any investigational or commercially available anti-hcv agents.

Keywords: chronic hepatitis c virus (hcv) genotype 1 - 6 metavir system fibrosis score glecaprevir pibrentasvir treatment naïve cirrhosis compensated cirrhosis
sitafloxacin and ertapenem treatment for acute urinary tract infection caused by e. coli or k. pneumoniae in post-kidney transplantation patients

Conditions: Anti-Infective Agents, Urinary; Escherichia Coli Infections; Klebsiella Infections; Kidney Transplantation; Urinary Tract Infections

Summary: this study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute urinary tract infection caused by extended spectrum beta lactamase producing escherichia coli or klebsiella pneumoniae in post-kidney transplantation. patients are treated with intravenous (iv) antibiotics follow by oral sitafloxacin or iv ertapenem.

a prospective randomized controlled trial of patients with a presumptive diagnosis of acute urinary tract infection caused by extended spectrum beta lactamase-producing escherichia coli or klebsiella pneumoniae in post-kidney transplantation. intravenous (iv) antibiotic is initially given to all patients. after day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. the course of treatment will complete within 14 days.

Eligibility criteria:
inclusion criteria: * age \>18 years * acute urinary infection by definitions * positive urine culture for extended spectrum beta lactamase e. coli or k. pneumoniae ≥105 colony forming unit/ml * post-kidney transplantation * voluntarily consented to be enrolled in the study exclusion criteria: * sepsis * positive blood culture * mixed organism of urine culture * immunocompromised conditions other than post-kidney transplantation * pregnancy or lactation * previous urinary tract infections within 4 weeks * contraindicated for fluoroquinolones and carbapenems

Keywords: extended-spectrum ß-lactamase-producing escherichia coli extended-spectrum ß-lactamase-producing klebsiella pneumoniae kidney transplantation urinary tract infections
pharmacokinetics of fluconazole iv as prophylaxis or therapy to icu patients

Conditions: Candidiasis

Summary: the pharmacokinetics of fluconazole are expected to be different in icu patients compared to non-icu patients. the investigators will determine fluconazole and free fluconazole concentrations in 20 icu patients, who will get intravenous fluconazole as standard care. switching to oral/enteral fluconazol is allowed after day 3. a full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken daily after intravenous therapy.

the pharmacokinetics of fluconazole are expected to be different in icu patients compared to non-icu patients and healthy volunteers due to underlying disease(s). therefore, extrapolation of data from healthy volunteers and non-icu patients is not possible. to be able to include 20 patients within the study duration, a multi-centre approach is necessary. patients will receive standard care, as stated in the product characteristics or according to local protocols. blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. a maximum of 62 milliliter blood in total will be drawn for this study. patients will be monitored daily during the treatment period for adverse events of the study drug. full pharmacokinetic curves will be taken on day 3 of iv therapy. limited pharmacokinetic curves will be taken on day 7 of iv therapy. these two moments of pharmacokinetic analysis will enable the determination steady state and enable the determination of intra-individual variability. as probably not all patients included will be treated with iv fluconazole for 7 days, switching to oral/enteral therapy is allowed after day 3. to assess bioavailability limited pharmacokinetic curves will be taken on day 3 of oral/enteral therapy.

Eligibility criteria:
inclusion criteria: 1. patient is admitted to an icu 2. subject is at least 18 years of age on the day of the first dosing 3. subject is managed with a central venous or arterial catheter exclusion criteria: 1. is known to be hypersensitive to azole antifungal agents 2. documented history of sensitivity to medicinal products or excipients similar to those found in the fluconazole preparation 3. has previously participated in this trial

Keywords: pharmacokinetics fluconazole invasive fungal infection candidiasis intensive care unit
omegaven® in the treatment of parenteral nutrition (pn) induced liver injury

Conditions: Total Parenteral Nutrition-induced Cholestasis

Summary: the purpose of this study is to determine whether the omega-3 fatty acid emulsion (omegaven®), when used in place of the conventional soy-based fat emulsion (intralipid), is effective in treating parenteral nutrition associated liver disease (pnald) in children. the study hypothesis is that omegaven® can be safely provided to children who are dependent on parenteral nutrition and have pnald, and can reverse or prevent progression of pnald until the child can take adequate nutrition by mouth.

rationale for omegaven® treatment unlike conventional intravenous fat emulsions, omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. animal studies have shown that iv lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). by administering omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate pn until they are able to ingest adequate nutrition enterally. references 1. chen w. effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. clinical nutrition 1996;15:24. 2. yeh s. effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. clinical nutrition 1996;15:80.

Eligibility criteria:
inclusion criteria: * children 0-18 years of age * patients will be pn-dependent and expected to continue pn for at least 30 days * patients considered eligible for study participation must have pn-associated liver diseases . other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. a liver biopsy is not necessary for treatment * direct bilirubin \> 2.0 mg/dl * signed patient informed consent * signed patient assent where applicable. exclusion criteria: * pregnancy * other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency) * signs of advanced liver disease including cirrhosis on biopsy, varices, ascites * the patient is allergic to eggs/shellfish * the patient has a severe hemorrhagic disorder * the patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) * the parent or guardian or child unwilling to provide consent or assent.

Keywords: pnald cholestasis omegaven® short bowel syndrome
excrossv multi site trial for vascularized high risk keratoplasty

Conditions: Corneal Transplant Failure

Summary: the main objective of this study is to determine the safety of ex vivo cross linking (cxl) of donor corneal tissue in participants who have undergone high-risk penetrating keratoplasty.

this is a randomized, double-masked, multi site clinical trial to determine the safety of ex vivo cxl of donor corneal tissue in 96 participants who have undergone high-risk penetrating keratoplasty. participants will be randomized to receive either a corneal tissue that has been untreated vs. a corneal tissue that has been treated with photrexa® viscous \& photrexa® and uv light. the tissue will be prepared by a corneal tissue bank under current-good-tissue-practice (cgtp) and delivered to the respective institutions for transplantation. participants will be monitored up to 24 months post-transplantation to assess for adverse events of the randomized tissue.

Eligibility criteria:
inclusion criteria: * age 18 and older * willing and able to provide written informed consent * willing and able to comply with study assessments for the full duration of the study * patients undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (nv) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal nv to the graft-host junction in a previously failed graft * superficial vessels are defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea (i.e., deep stroma). superficial cnv involving ≤2 quadrants (equivalent to ≤6 clock hours) without deep cnv are classified as mild. cnv with \>2 quadrants of superficial vessels (\>6 clock hours) or 1 quadrant of deep vessels (\>3 clock hours) as severe (36). exclusion criteria: * history of stevens-johnson syndrome or ocular pemphigoid * ocular or periocular malignancy * non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively * uncontrolled glaucoma * change in topical corticosteroid regimen within 14 days of transplantation * use of systemic immunosuppressive for indication other than corneal graft rejection * participation in another simultaneous medical investigation or trial * pregnancy (positive pregnancy test) or lactating * pre-menopausal women not using adequate contraception (reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method) * ocular infection within 30 days prior to study entry. * presence of anterior chamber intraocular lens * active uveitis within 90 days prior to the study entry. * no ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.

Keywords: keratoplasty cross linking
bioimpedance analysis in perioperative assessment in thoracic surgery

Conditions: Lung Resection; Adenocarcinoma of Lung

Summary: the assessment of surgical and postoperative risks in thoracic surgery is a field of significant interest because the surgical procedure causes substantial changes in the body's homeostasis. the postoperative course is characterized by considerable clinical variability compared to the preoperative classification, which highlights more homogeneous data among various patient groups. this variability appears to result from individual differences in response to extensive pulmonary resections. notably, the homogeneity of preoperative data does not correlate with the greater variability observed in the postoperative course. the application of algorithms derived from biva in bioimpedance studies has proven particularly useful for prognostic assessments in oncology, as it can evaluate a patient's hydration status and muscle reserves at the time of diagnosis or the start of clinical/surgical treatment. understanding body composition, particularly the quantity and/or quality of muscle mass, is essential for diagnosing sarcopenia. by passing a low-intensity alternating current (imperceptible to the patient) through the body, biva measures provide insights into body water distribution (both intracellular and extracellular), lean mass and skeletal muscle mass. overall, the test offers a detailed picture of hydration status and skeletal muscle composition. another validated tool for assessing sarcopenia, which provides information on both muscle quantity (via cross-sectional area measurements) and muscle quality (via muscle density measurements), is computed tomography (ct). ct imaging is typically performed for diagnostic and staging purposes before surgery in thoracic surgery patients, either alone or in combination with positron emission tomography (pet). our study will focus on assessing correlations between clinical, imaging, and bioimpedance data and postoperative outcomes, with particular attention to the incidence of atrial fibrillation (af), pulmonary atelectasis requiring treatment, and increased pleural drainage production. additionally, we will evaluate the relationship between the surgical approach (open surgery vs. video-assisted thoracoscopic surgery, or vats) and short-term bioimpedance values.


Eligibility criteria:
inclusion criteria: - patients undergoing pulmonary resection surgery for primary neoplasm within a one-year timeframe. exclusion criteria: * patients with chronic atrial fibrillation (af). * patients who have previously undergone major pulmonary resection. * patients with pacemakers or implantable devices, as the use of bioimpedance vector analysis (biva) may be contraindicated.

Keywords: bioimpedence lung cancer sarcopenia
mirna in kidney transplantation: association with kidney graft function and disease process

Conditions: Kidney Transplant Failure and Rejection

Summary: micrornas (mirnas) belong to a class of small non-coding rnas that modulate physiological and pathological processes by post-transcriptional regulation of gene expression mainly via translational inhibition of target messenger rnas. recently, many mirnas were found to be involved in pathological processes that occur following kidney transplantation, like allograft rejection, de novo disease or disease recurrence after kidney transplantation. as most of the mirnas involved in kidney diseases are extracted by urine, the diagnostic accuracy of such molecules as biomarkers is questionable. the aim of this study is to analyze expression of selected mirnas (mir-29c, mir-126, mir-146a, mir-150, mir-155, mir-223) and evaluate whether their regulation is associated with kidney graft function and disease processes after kidney transplantation (ktx).

micrornas (mirna) are short, endogenous non-coding rnas involved in the modulation of gene expression mainly by inhibition of messenger rnas translation. recent studies have indicated association of mirnas with pathological processes following kidney transplantation. the aim of the study is to determine whether selected mirnas are related to specific disease process or only reflect kidney graft function. the study enrolled 100 caucasian ktrs, who presented with stable renal function (as indicated by stable serum creatinine (cr) for 3 months and whose kidney graft function was thereafter estimated with various methods, including: cystatin c concentration, three different ckd epi equations and measured with chromium-51 ethylenediamine tetraacetic acid clearance. expression of 6 selected mirnas (mir-29c, mir-126, mir-146a, mir-150, mir-155, and mir-223) was determined by qpcr using mirna-103a, mir-191, and mir-423 as reference genes.

Eligibility criteria:
inclusion criteria: * time of kidney transplantation at least 2 years before the study entry, * stable function of the transplanted kidney during the previous 3 months (changes in s-creatinine ≤ 20%). exclusion criteria: * age less than 18 years, * symptomatic heart failure, * malignancy, * pregnancy or lactation, * acute conditions and diseases that can affect the gfr, * newly-introduced drugs that may affect the function of the graft, * treatment with trimethoprim-sulfamethoxazole or cimetidine, * the presence of a pacemaker or any other electronic device in the body.

Keywords: mirna kidney transplant function kidney transplant rejection disease recurrence cystatin micro rna